Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of a New Online Programme for Physical Activity and Healthy Eating.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032731
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Elisabeth Grey, University of Bath

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE January 16, 2017
Actual Primary Completion Date September 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Change in mean daily physical activity level (PAL) [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Mean daily physical activity level (PAL) will be assessed using accelerometers (BodyMedia, worn on the upper arm), worn for a continuous 7-day period, being removed during this time only for water-based activities such as showering or swimming. The accelerometers gather minute by minute total energy expenditure (TEE) data, which will be used to calculate PAL (PAL = TEE/BMR, where BMR = basal metabolic rate, to be calculated using the Schofield equation).
  • Change in mean daily energy intake (EI) [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Mean daily energy intake (EI) will be assessed using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day .
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Fasting plasma glucose concentration [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of glucose concentration in the blood plasma at rest across all three measurement points.
  • Fasting plasma insulin concentration [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of insulin concentration in the blood plasma at rest across all three measurement points.
  • Fasting triglyceride concentration [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of triglyceride concentration in the blood serum at rest across all three measurement points.
  • Fasting total cholesterol concentration [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of total concentration in the blood serum at rest across all three measurement points.
  • Fasting LDL cholesterol concentration [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of LDL concentration in the blood serum at rest across all three measurement points.
  • Fasting HDL cholesterol concentration [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of HDL concentration in the blood serum at rest across all three measurement points.
  • C-reactive protein (CRP) concentration [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of CRP concentration in the blood serum at rest across all three measurement points.
  • Body mass index (BMI) [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of BMI (defined as mass in kg divided by height in metres squared) across all three measurement points.
  • Waist circumference [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of waist circumference (in centimetres) across all three measurement points.
  • Blood pressure [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Comparison of blood pressure (systolic/diastolic mmHG) across all three measurement points.
  • Quality of diet [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Diet quality will be assessed based on the proportion of fibre, free sugars and refined carbohydrates, and saturated fats in the diet. The intervention aims to promote an increase in fibre intake and decrease in free sugar, refined carbohydrate and saturated fat intake. Data will be collected using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day.
  • Motivation for physical activity [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland & Tobin, 2004; Wilson, Rodgers, Loitz & Scime, 2006) adapted for physical activity.
  • Motivation for healthy eating [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland & Tobin, 2004; Wilson, Rodgers, Loitz & Scime, 2006) adapted for diet.
  • Self-efficacy for physical activity and healthy eating [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Self-efficacy will be measured using the Barriers Self-Efficacy Scale for Exercise (BARSE; McAuley, 1992) adapted for physical activity.
  • Self-efficacy for healthy eating [ Time Frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period ]
    Self-efficacy will be measured using the self-efficacy scale for eating a healthy diet developed by Pawlak and Colby (2009).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of a New Online Programme for Physical Activity and Healthy Eating.
Official Title  ICMJE Trial of a Self-directed Behaviour Change Intervention for Physical Activity and Healthy Eating.
Brief Summary

Many healthy lifestyle interventions have been developed to help people change their activity and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and cardiovascular disorders (CVD). However, these interventions often fail to engage their target audience, which undermines their effectiveness in changing behaviour and health outcomes.

The purpose of this study is to investigate the effectiveness of a self-directed, website-based intervention to promote physical activity and healthy dietary behaviours. The intervention frames health information from a novel perspective, which our previous work has indicated can help to promote interest in the health information and improve attitudes, self-efficacy and motivation towards physical activity and healthy dietary behaviours.

The intervention comprises a website of information resources and personal recording areas to set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim to see whether the intervention has any impact on people's physical activity and diet, as well as their risk of developing CVD and T2DM. The intervention will be compared with a control condition in which participants will be shown standard resources available on NHS websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be recruited from the community. The active intervention will last 6 weeks (during this period participants will receive weekly emails from the research team) and there will be a 6-week follow-up phase (in which participants will still have access to the website but contact from the research team). Activity, diet, disease risk markers and psychological antecedents of behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12- weeks).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Prevention
Condition  ICMJE Overweight/Obesity
Intervention  ICMJE
  • Behavioral: Website and pedometer intervention
    Self-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change.
  • Other: Control
    Standard, publicly available NHS resources for healthy lifestyles.
Study Arms  ICMJE
  • Experimental: Website and pedometer Intervention
    Participants allocated to this group will be given a one-off set-up session in which a researcher will show them the intervention website, create a user profile for them and provide guidance on how to use the site to gain health information, set personal behavioural goals and record and monitor their behaviour in relation to their goals. The researcher will also provide the participant with a pedometer and instruct them how to use this and where they can record their daily steps on the website. For 6 weeks, participants will be asked to use the website and be sent weekly email reminders to do so and log their goal progress. After 6 weeks, no further emails will be sent but participants will still be able to access the website and use the pedometer if they wish.
    Intervention: Behavioral: Website and pedometer intervention
  • Control
    Participants allocated to this group will be given a one-off session in which a researcher shows them publicly available web-based resources for health behaviour change (provided by the National Health Service (NHS)). Like those participants in the intervention group, they will be assessed again after 6 and 12 weeks. Participants in the control arm will be offered the intervention (access to the study website and a pedometer) after 12 weeks.
    Intervention: Other: Control
Publications * Grey EB, Thompson D, Gillison FB. Effects of a Web-Based, Evolutionary Mismatch-Framed Intervention Targeting Physical Activity and Diet: a Randomised Controlled Trial. Int J Behav Med. 2019 Dec;26(6):645-657. doi: 10.1007/s12529-019-09821-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
59
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
60
Actual Study Completion Date  ICMJE September 12, 2017
Actual Primary Completion Date September 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to give informed consent to participate in the study.
  • Male or female and aged between 35-74 years.
  • Defined as overweight or obese, i.e. BMI>25kg/m2.
  • Able to travel to the university for assessment days.

Exclusion Criteria:

  • Individuals who are not fluent in the English language, and who do not have access to and do not regularly use the internet and an email account.
  • Individuals diagnosed with coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, severe hypertension (BP>180/110mmHg) and peripheral arterial disease.
  • BMI>40kg/m2 (morbidly obese).
  • Currently using weight loss drugs or other medication that can affect weight.
  • Any reported recent (i.e. last 6 months) shift (>5%) in body mass or large change in habitual lifestyle.
  • Individuals unable to change their physical activity (e.g. through disability).
  • Current (pre-baseline) or recent (i.e. last 2 months) participation in another research trial or lifestyle supportive intervention or referral.
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032731
Other Study ID Numbers  ICMJE EP 16/17 034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elisabeth Grey, University of Bath
Study Sponsor  ICMJE University of Bath
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dylan Thompson, PhD University of Bath
PRS Account University of Bath
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP